Peter Leon Email & Phone Number

Greater Boston

Morrisville, North Carolina, Us

Commissioning, Qualification and Validation Engineer at Moderna Therapeutics:CQV Lead for Process Equipment at a newly developed commercial facility• Led and guided a team of engineers on-site at Moderna's new commercial manufacturing facility• Worked as an extension of Modern's internal validation engineering team and worked alongside cross-functional departments, including process engineering, manufacturing, and process development• Delegated CQV deliverables to the CQV team and assisting in project issue management to drive path forward• Responsible for project management, as well as drafting and executing, as applicable, process equipment start-up, commissioning, and qualification deliverables for greenfield commercial manufacturing facility• Systems include custom built skids for Chromatography, Tangential Flow Filtration, and Mixing system, as well as commercial off-the-shelf production equipment (e.g., Filter Integrity Testers, Spectrophotometers, Balances, BSCs, Pumps, etc.)• Deliverables include Impact Assessments, User Requirement Specifications, Design Qualifications, Risk Assessments, Commissioning and Qualification protocols, Acceptance and Release reports• Monitored CQV execution to ensure applicable testing and start up activities are complete and leverageable• Identified, escalated, and tracked escalations and punch list items during commissioning and qualification to control cost and schedule• Provided on the floor troubleshooting support for automated downstream processing equipment (e.g., Chromatography, Tangential Flow Filtration, and Mixing systems) for Moderna’s proprietary mRNA and LNP technology• Provided a technical assessment of failure mode in a timely fashion with recommended remediation actions• Lead continuous improvement projects to meet new process requirements and improve current processes• Owned quality events and quality actions to remediate system issues, and improve current processes

Morrisville, North Carolina, Us

CQV Engineer at Moderna Therapeutics:- Commissioning, Qualifying, and Validating Systems and Equipment at Moderna Therapeutics

Automation Engineer at Cytiva:- Testing control system software on Cytiva’s Next Generation equipment platform including Single Use Bioreactors from 50L to 10000L- Maintaining project documentations such as Software Design Specifications, P&IDs, and PLC Rockwell code- Recording, reporting, and troubleshooting biopharmaceutical equipment defects through the acts of software review and hands-on testing- Daily management of project activities and deliverables

Andover, Ma, Us

- Detailed process and analysis testing of failed products. - Investigated gross failure trends to understand and fix the issues. - Worked with engineers on long-term projects to improve overall production efficiency.

Andover, Ma, Us

- Detailed process and analysis testing of failed products. - Investigated gross failure trends to understand and fix the issues. - Worked with engineers on long-term projects to improve overall production efficiency.

Franklin Lakes, Nj, Us

- Shadowed the CFO and CEO during my time there. - Researched better ways of inserting insulin in a diabetic's body.- Presented my results to a panel of engineers and executives describing the best result, cost-wise and as well as effectiveness.